Added value of a balloon-based mucosal exposure device in computer-aided detection-assisted colonoscopy: a randomized...

Area of Science:

• Gastroenterology
• Endoscopy
• Cancer Screening

Background:

• Computer-aided detection (CADe) and mucosal exposure devices enhance adenoma detection during colonoscopy.
• Fecal immunochemical testing (FIT) is a common method for colorectal cancer screening.

Purpose of the Study:

• To evaluate if combining a CADe system with a balloon-based mucosal exposure device increases the identification of high-risk colonoscopy findings in a FIT-based screening program.
• To assess the impact on adenoma detection rate (ADR).

Main Methods:

• A multicenter, open-label, parallel-arm randomized controlled trial was conducted.
• FIT-positive subjects were randomized to either CADe-assisted colonoscopy with a balloon device or CADe-assisted colonoscopy alone.
• The primary endpoint was the rate of high-risk findings (ESGE criteria), and the secondary endpoint was ADR.

Main Results:

• No significant difference was found in high-risk findings between the CADe+balloon arm (19.3%) and the CADe arm (23.1%) (P=0.24).
• Adenoma detection rates were also similar: 55.4% for CADe+balloon versus 59.1% for CADe (P=0.32).
• No adverse events were reported during the study.

Conclusions:

• In a FIT-based screening program, adding a balloon-based mucosal exposure device to CADe-assisted colonoscopy did not improve the detection of high-risk features or neoplastic lesions.
• A potential CADe-related ceiling effect may have limited the benefit of the additional device.